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The FDA Ruling on Avandia…

August 1, 2007

July 31 was a big day for Avandia after the US FDA ruled out removing the drug from the market. The FDA hearing looked at several arguments whether indeed Avandia can result in increased risk of heart disease.

The US Food and Drug Administration’s (FDA’s) Advisory Committee came to an almost unanimous decision yesterday, voting 22-1 for Avandia, GlaxoSmithKline’s much-maligned diabetes treatment, to remain on the US market.

Concern about side effects associated with Avandia (rosiglitazone) was raised by a meta-analysis published in the New England Journal of Medicine in May. The analysis, led by Steven Nissen of the Cleveland Clinic, Ohio, US, concluded that the drug increased the risk of heart attack and death .

The committee convened to evaluate all of the post-approval clinical data and assess the ‘overall risk-benefit profile’ of the drug.

During a press conference following the meeting, the acting committee chair, Clifford Rosen from the Maine Center for Osteoporosis, Bangor, US, highlighted a ‘significant number of caveats’ for the prescription of Avandia.

‘I think there are clear-cut reasons not to use this drug in certain types of diabetes patients,’ he said. ‘These include those with or prone to congestive heart failure and people with significant risk of cardiovascular disease.’

The FDA will now consider the panel’s recommendations and make its final decision about what action to take. This could include the addition of appropriate warning labels on the drug’s packaging and the provision of advice to prescribing doctors.

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In short… just like any other drug out there…prudent use of this drug among our patients is necessary. Never to use among older patients at risk for heart disease and those with significant risk factors for heart disease especially among those already on insulin. The problem is that majority of patients are put on insulin by doctors late after several years of poorly controlled diabetes… such that complications especially heart disease have already set in. I dont believe this to be the case among young patients whom we start Early Insulinization where the risk for heart disease is not the same as somebody put on insulin late in the disease process.

All along I was right. I believe in the efficacy of this drug so I was confident based on the available data that more studies need to be done. Metformin and Pioglitazone on their initial short term studies proved harmful but long term studies proved otherwise! I am sure that the longer duration studies will prove also Avandia to be worth taking to reduce ones risk for heart disease.